This draft guidance provides the U.S. Food and Drug Administration's (FDA) current thinking on the implementation of the mandatory cosmetics recall provisions under section 611 of the Federal Food, Drug, and Cosmetic (FD&C) Act, as added by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Presented in a question-and-answer format, the document clarifies the scope of products subject to mandatory recall, the criteria FDA uses to invoke this authority, the process for ordering a recall, and the responsibilities of the "responsible person".

Contents

I. Introduction

II. Background

III. Questions And Answers